scholarly journals International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use (ICH).

1994 ◽  
Vol 37 (5) ◽  
pp. 401-404 ◽  
Author(s):  
N. Baber
Keyword(s):  
International Conference ◽  
Technical Requirements ◽  
Human Use

scholarly journals Challenges Faced During eCTD and CTD Filling Procedures for USFDA and Canada

2019 ◽  
Vol 9 (4-s) ◽  
pp. 673-679
Author(s):  
Nisar Ahammad ◽  
Nagarjuna Reddy ◽  
M.V. Nagabhushanam ◽  
Brahmaiah Ramakrishna
Keyword(s):  
Technical Information ◽  
Technical Document ◽  
Medical Products ◽  
International Conference ◽  
Registration Process ◽  
Regulatory Affairs ◽  
Technical Requirements ◽  
Drug Registration ◽  
The Common ◽  
Human Use

Electronic Common Technical Document (eCTD) is a topic of increasing interest in the pharmaceutical Industry as it become compulsory for filing procedures.  The Common Technical Document (CTD) is a set of specification for application dossier, for the registration of Medicines and designed to be used across Europe, Japan and the United States.Quality, Safety and Efficacy information is assembled in a common format through CTD .The CTD is maintained by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Electronic common technical documentis an interface used by applicants of marketing authorisation for medical products to submit regulatory affairs document to the agency concerned. The purpose of this article is to present a concise overview of challenges faced during eCTD & CTD submissions in United States and Canada. A regulatory process, by which a person/organization/ sponsor/innovator gets authorization to launch a drug in the market, is known as registration process. The registration process will be done by submitting technical information to the authority Keywords: electronic common technical document (ECTD)/ (CTD), International conference on hormonisation (ICH), Drug registration process.

Understanding Race at the Frontier of Pharmaceutical Regulation: An Analysis of the Racial Difference Debate at the ICH

2008 ◽  
Vol 36 (3) ◽  
pp. 498-505 ◽  
Author(s):  
Wen-Hua Kuo
Keyword(s):  
Health Care ◽  
Racial Difference ◽  
National Level ◽  
The Other ◽  
Rudyard Kipling ◽  
International Conference ◽  
Technical Requirements ◽  
Human Use ◽  
East And West ◽  
The Many

Reflecting on the tension of which he was aware between the imperial West and the still-mysterious East, Victorian writer Rudyard Kipling (1865-1936) penned the above phrase to express the incommensurable situation wherein the Westerner never understands the Asian, as the latter’s culture differs too greatly from his own. However, aware that East and West nevertheless cannot remain separated forever, the author ends the poem with an eventual encounter between the two.Over 100 years have passed since this poem was written, yet the ambivalent encounter between East and West that it depicts still exists and is currently playing out within the field of pharmaceuticals. On one side of the divide are the many people in the industry who want to standardize global acceptance of drugs; on the other are the local authorities who want to maintain the overruling legal need not to compromise on health care at a national level. In this sense, the divergence and unity that Kipling captures is what this paper aims to discuss as it addresses how race is debated at the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

scholarly journals Comparison Of L-Dopa Content In Three Species Of Genus Mucuna By Different Extraction Techniques

2018 ◽  
Vol 7 (1) ◽  
pp. 1973
Author(s):  
Ragni Vora ◽  
Ambika N. Joshi ◽  
Nitesh Chandulal Joshi
Keyword(s):  
Extraction Efficiency ◽  
Extraction Methods ◽  
Mucuna Pruriens ◽  
Water Mixture ◽  
Extraction Techniques ◽  
International Conference ◽  
Technical Requirements ◽  
Rp Hplc ◽  
Human Use ◽  
Seed Extracts

In the present study, attempts are made to develop suitable method(s) for extraction of L-DOPA from the powdered seeds of 3 species of Mucuna using different solvents and conditions. The seed powder of both plants was subjected to 6 different extraction methods, with different solvent ratios. All the extracts were analyzed using RP-HPLC and was validated according to The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use guidelines. The L-DOPA extraction was best with Methanol Water mixture in a cold maceration technique and overall gives good extraction efficiency in all the three plants giving concentrations of 5.03%, 13.36 % and 16.78% of L-DOPA in Mucuna gigantea, Mucuna pruriens and Mucuna monosperma, respectively. The present investigation was done to study the extraction efficiency of various extraction methods of L-DOPA content in seed extracts of Mucuna and compare it.

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